Use of Registries in Regulatory Decision Making

The More-EUROPA project is working towards a more efficient use of real-world data in the development, registration and assessment of medicinal products in Europe. It focuses on the value and use of registry-based real-world data in augmenting clinical trial data in the regulatory and health technology assessment decision-making process.

In this training session on 21 November from 14:00-16:00 CEST, you'll have the opportunity to:

• Get the latest updates on registry-based activities in the context of healthcare research and data utilization.
• Understand the European Medicines Agency’s guidelines for registry-based studies, enhancing their ability to navigate regulatory processes effectively.
• Explore a specific case study on the use of registry-based real-world data in the regulatory process.
• Engage in a Q&A session with Health Technology Assessment (HTA) bodies and regulators. An opportunity for participants to engage with experts, ask questions, and foster collaboration in the field of healthcare research and technology assessment.

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This is the first of a series of webinars and future topics will include:

• How to appraise and apply machine learning and/or artificial intelligence approaches to identify relevant registries, additional data and determine relevant confounders and outcomes;
• How real-world data elements can augment clinical trial performance, and how to use registries as a source for external comparator data;
• Methods to access registry data, data sharing (consent and privacy), and federated analyses;
• How to evaluate and design registry based RCTs.

➔ Learn more about More-EUROPA